Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy (I-COMBINE)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00956644
First received: August 10, 2009
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

Primary Objective:

  • To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5)

Secondary Objective:

  • To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5)
  • To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of treatment (W10)
  • To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM)
  • To determine the incidence and severity of adverse events

Condition Intervention Phase
Hypertension
Drug: irbesartan/amlodipine
Drug: amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Mean home systolic blood pressure [ Time Frame: At randomisation and week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean office blood pressure [ Time Frame: At randomisation, week 5 and week 10 ] [ Designated as safety issue: No ]
  • Mean home diastolic blood pressure [ Time Frame: At randomisation, week 5 and week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 406
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: irbesartan/amlodipine
Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks
Drug: irbesartan/amlodipine
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning
Active Comparator: amlodipine
Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks
Drug: amlodipine
Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Established essential hypertension
  • Treated with amlodipine 5 mg monotherapy for at least 4 weeks
  • With uncontrolled BP defined as mean SBP = or > 145 mmHg assessed by OBPM
  • Signed written inform consent obtained prior to inclusion in the study

Randomisation Criteria:

  • Mean SBP = or > 135 mmHg assessed by HBPM
  • Good compliance with the HBPM protocol defined as at least 12 correct measurements performed over the last 6 days of the first period of measurements
  • Creatinine clearance = or > 30 ml/min, determined by Cockroft formula

Exclusion criteria:

  • Mean SBP = or > 180 mm Hg and/or mean DBP = or > 110 mm Hg measured at doctor's office at Visit 1
  • Known or suspected causes of secondary hypertension
  • Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only one functioning kidney
  • Know contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
  • Known type 1 diabetes
  • Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal or history or hepatic encephalopathy, esophageal varices, or portocaval shunt
  • Known severe renal impairment (creatinine clearance < 30 ml/mn)
  • Concomitant use of any other antihypertensive treatment
  • Administration of any other investigational drug within 30 days before inclusion
  • Inability to obtain a valid automatic BP measurement recording
  • Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the patient
  • Presence of any other conditions (e.g.: geographical, social, etc) that would restrict or limit the patient participation for the duration of the study
  • Pregnant or breast feeding women
  • Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956644

  Hide Study Locations
Locations
Brazil
Sanofi-Aventis Investigational Site Number 07602
Campinas, Brazil, 13059-900
Sanofi-Aventis Investigational Site Number 07605
Rio de Janeiro, Brazil, 20551-030
Sanofi-Aventis Investigational Site Number 076-005
Rio de Janeiro, Brazil, 20551-030
Sanofi-Aventis Investigational Site Number 07604
São José, Brazil, 88103-460
Sanofi-Aventis Investigational Site Number 07601
São Paulo, Brazil, 04025-011
Sanofi-Aventis Investigational Site Number 07603
São Paulo, Brazil, 05403-000
Sanofi-Aventis Investigational Site Number 076-002
São Paulo, Brazil, 05403-000
Sanofi-Aventis Investigational Site Number 076-004
São Paulo, Brazil, 04038-002
Chile
Sanofi-Aventis Investigational Site Number 15205
Santiago, Chile
Sanofi-Aventis Investigational Site Number 15204
Santiago, Chile
Sanofi-Aventis Investigational Site Number 15206
Santiago, Chile
Sanofi-Aventis Investigational Site Number 15203
Santiago, Chile
Sanofi-Aventis Investigational Site Number 15202
Santiago, Chile
Colombia
Sanofi-Aventis Investigational Site Number 17003
Barranquilla, Colombia
Sanofi-Aventis Investigational Site Number 17004
Barranquilla, Colombia
Sanofi-Aventis Investigational Site Number 17002
Medellin, Colombia
Egypt
Sanofi-Aventis Investigational Site Number 81804
Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 81803
Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 81802
Cairo, Egypt
Sanofi-Aventis Investigational Site Number 81801
Cairo, Egypt
Lebanon
Sanofi-Aventis Investigational Site Number 42204
Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 42203
Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 42202
Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 42205
Beirut, Lebanon
Sanofi-Aventis Investigational Site Number 42206
Beirut, Lebanon
Mexico
Sanofi-Aventis Investigational Site Number 48401
Durango, Mexico, 34080
Sanofi-Aventis Investigational Site Number 48404
Guadalajara, Mexico, 44680
Sanofi-Aventis Investigational Site Number 48402
Guadalajara, Mexico, 44656
Sanofi-Aventis Investigational Site Number 48403
Guadalajara, Mexico, 44656
Sanofi-Aventis Investigational Site Number 48406
Guadalajara, Mexico, 44670
Sanofi-Aventis Investigational Site Number 48405
Mexico, Mexico, 06140
Sanofi-Aventis Investigational Site Number 48407
Mexico, Mexico, 07330
Morocco
Sanofi-Aventis Investigational Site Number 50401
Casablanca, Morocco
Sanofi-Aventis Investigational Site Number 50403
Marrakech, Morocco
Sanofi-Aventis Investigational Site Number 50402
Marrakech, Morocco
Tunisia
Sanofi-Aventis Investigational Site Number 78804
Ariana, Tunisia
Sanofi-Aventis Investigational Site Number 78803
Monastir, Tunisia, 5000
Sanofi-Aventis Investigational Site Number 78802
Sfax, Tunisia
Sanofi-Aventis Investigational Site Number 78801
Tunis, Tunisia
Venezuela
Sanofi-Aventis Investigational Site Number 86201
Caracas, Venezuela
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie Genes, MD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00956644     History of Changes
Other Study ID Numbers: IRBAM_R_04220
Study First Received: August 10, 2009
Last Updated: October 25, 2010
Health Authority: Mexico: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Irbesartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 28, 2014